Quality Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. ## **JOB DESCRIPTION:** ## **Quality Engineer** **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with a high employer contribution. - Tuition reimbursement, the [Freedom 2 Save](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This position works out of our **Santa Rosa, CA** location in the **Toxicology** business within Abbott's Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The **Quality Engineer** will execute highly complex and specialized quality assurance projects supporting Abbott's Toxicology business, including clinical and forensic laboratory operations, drugs-of-abuse testing, quality systems compliance, and continuous improvement initiatives. This role applies advanced quality principles and analytical techniques to ensure compliance with applicable regulatory, accreditation, and quality standards. The Quality Engineer will serve as a key contributor to Quality Management System effectiveness, laboratory quality oversight, audit readiness, validation activities, process improvement, and regulatory compliance while partnering cross-functionally to deliver high-quality products and services that meet customer and business requirements. **What You’ll Work On** - Works on problems of diverse scopes and complexity where analysis of data, regulatory requirements, and considerable judgment and initiative are required to reach resolution or provide recommendations. - Leads and/or contributes to quality system, test method, quality assurance, and operational process improvement projects. - Supports and may administer Quality Management System processes including CAPA, document control, training, supplier quality, change control, management review, and quality metrics. - Conducts complex analysis of quality records, laboratory data, audit findings, investigations, trends, and reports to identify opportunities for continuous improvement. - Supports equipment, process, facility, software, and test method qualification, validation, verification, and change control activities. - Conducts inspection, verification, and validation of components, materials, systems, and processes used in development, laboratory, and manufacturing activities. - Conducts and supports internal audits and external inspections, including CLIA and CAP, customer, and supplier audits, and ensures timely implementation of corrections and corrective actions. - Ide…